- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03683537
Association Between Changes of GFAP After Surgery and Postoperative Delayed Cognitive Recovery
June 21, 2019 updated by: Moscow Clinical Scientific Center
Assessment of serum level of glial fibrillary acidic protein (GFAP) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day.
Neuropsychological testing before surgery and on 3 or 4 day after surgery.
Investigation of relationship between changes of GFAP and scores of neuropsychological tests.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sergey Kamnev, M.D.
- Phone Number: +0079055918462
- Email: korium1605@gmail.com
Study Locations
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-
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Moscow, Russian Federation, 111123
- Recruiting
- Moscow Clinical Scientific Center
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Contact:
- Sergey Kamnev, M.D.
- Phone Number: +0079055918462
- Email: korium1605@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who undergo surgery in Moscow Clinical Scientific Center
Description
Inclusion Criteria:
- Patients with different diseases, who require prolonged laparoscopy or open surgery
- Age more than 60
- ASA I-III
- Informed consent to participate in the study
Exclusion Criteria:
- ASA IV-V
- Severe neurodegenerative or psychological diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Delayed Neurocognitive decline
Patients in whom there is Delayed Neurocognitive Recovery (DNR) after surgery, based on neuropsychological tests or clinically.
DNR is defined as follow: 1)decrease of scores of neuropsychological test scores for more than 1 standard deviation (SD) of these tests; 2)clinically - inability of patient to perform test after surgery because of neurocognitive impairment.
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3 samples of serum are drawn from patients.
The 1st Sample of patient serum is drawn before induction into anesthesia.
The 2nd is drawn 24 hours after the 1st one.
The 3rd sample is drawn on 3 or 4 postoperative day.
All samples collected and preserved in the same temperature as required for ELISA.
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Normal postop neurocognitive function
Patients in whom there is no clinical signs of DNR, defined as in previous group.
|
3 samples of serum are drawn from patients.
The 1st Sample of patient serum is drawn before induction into anesthesia.
The 2nd is drawn 24 hours after the 1st one.
The 3rd sample is drawn on 3 or 4 postoperative day.
All samples collected and preserved in the same temperature as required for ELISA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in serum GFAP
Time Frame: 1 year
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GFAP(3) - GFAP (1); GFAP (2) - GFAP (1)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Valery Subbotin, Ph.D., M.D., Moscow Clinical Scintific Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2018
Primary Completion (ANTICIPATED)
July 15, 2019
Study Completion (ANTICIPATED)
September 15, 2019
Study Registration Dates
First Submitted
September 20, 2018
First Submitted That Met QC Criteria
September 21, 2018
First Posted (ACTUAL)
September 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 24, 2019
Last Update Submitted That Met QC Criteria
June 21, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKNC 02/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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